Evidence map›Paper›PMID 35633034›Full record

Trial reportOrthopaedic surgery2022

Effectiveness and Feasibility of Injectable Escherichia coli-Derived Recombinant Human Bone Morphogenetic Protein-2 for Anterior Lumbar Interbody Fusion at the Lumbosacral Junction in Adult Spinal Deformity Surgery: A Clinical Pilot Study.

Sang-Kyu Im, Jung-Hee Lee, Ki Young Lee, Seung-Jin Yoo

Open access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Orthopaedic surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Application ofBioengineering (Basel, Switzerland) · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Sang-Kyu ImDepartment of Orthopedic Surgery, Graduate School, College of Medicine, Kyung Hee University, Seoul, South Korea.
Jung-Hee LeeDepartment of Orthopedic Surgery, Graduate School, College of Medicine, Kyung Hee University, Seoul, South Korea.ORCID https://orcid.org/0000-0002-1755-526X
Ki Young LeeDepartment of Orthopedic Surgery, Graduate School, College of Medicine, Kyung Hee University, Seoul, South Korea.ORCID https://orcid.org/0000-0002-0362-5634
Seung-Jin YooDepartment of Radiology, College of Medicine, Hanyang University, Seoul, South Korea.
Kyung Hee University · KRHanyang University · KR

Funding

Korea Health Industry Development Institute HI17C2026Ministry of Health
6 · The paper itself

Abstract

objectiveTo explore the effectiveness and feasibility of injectable Escherichia coli-derived recombinant human bone morphogenetic protein-2 (injectable E-rhBMP-2, a combination of E. coli-derived recombinant human bone morphogenic protein-2 and a hydrogel type beta-tricalcium phosphate carrier) as a bone substitute for anterior lumbar interbody fusion (ALIF) of the lumbosacral junction in adult spinal deformity (ASD) patients.

methodsA prospective single-institution therapeutic exploratory trial was conducted. Twenty patients (average age: 69.1 years; 19 female and one male; average fusion level: 7.95) diagnosed with ASD with sagittal imbalance who underwent surgical treatment including ALIF at the lumbosacral junction from December 2017 to January 2019 were evaluated. Injectable E-rhBMP-2 was prepared by dissolving 3 mg of E. coli-derived recombinant human bone morphogenetic protein-2 in 1.5 ml H

resultsOf the 20 patients, loss to follow-up occurred with one patient at 6 months after surgery and one patient at 12 months after surgery, resulting in a total of 18 patients who were available for follow-up. Six months after surgery, 68.4% patients achieved solid fusion. Twelve months after surgery, 100% fusion rate was achieved. Compared to baseline values, ODI scores improved to 45.8% and 63.7%, VAS (back) improved to 69.2% and 72.8%, and VAS (leg) improved to 49.2% and 64.8%, respectively, at 6 and 12 months after surgery (p < 0.001 for all). Ten cases of adverse events occurred. But no adverse events were associated with injectable E-rhBMP-2.

conclusionInjectable E-rhBMP-2 will be an effective bone graft substitute when achieving solid interbody fusion in the lumbosacral junction.

Indexed as

Bone SubstitutesSpinal FusionAdultAgedBone Morphogenetic Protein 2Escherichia coliFeasibility StudiesFemaleHumansHydrogelsLumbar VertebraeMalePilot ProjectsProspective StudiesRecombinant ProteinsTransforming Growth Factor betaBone Morphogenetic Protein 2Bone SubstitutesHydrogelsrecombinant human bone morphogenetic protein-2Recombinant ProteinsTransforming Growth Factor betaadult spinal deformityanterior lumbar interbody fusionbeta-tricalcium phosphatebone morphogenetic proteinlumbosacral junction

Identifiers

PMID35633034
PMCPMC9251273
OpenAlexW4281789671

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.